Polyneuropathy, Impairments and Physical Activity - The PolyImPAct Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Validity and reliability of outcome measures in polyneuropathy, Healthy controls.
- Who it may be relevant to
- Registry conditions: Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Vasculitic Neuropathy, POEMS Syndrome, Multifocal Motor Neuropathy. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
The project aims to investigate the validity, and reliability of outcome measures of muscle strength, functioning (gait, balance, and fine motor skills), physical activity, and patient-reported outcome measures of functioning (gait, balance, and fine motor skills), and daily living among patients with polyneuropathy. Further, the project aims to compare physical activity and patient-reported outcome measures of functioning (gait, balance, and fine motor skills), and daily living among patients with polyneuropathy with physical activity and patient-reported outcome measures of functioning (gait, balance, and fine motor skills) and daily living in healthy adults.
Detailed description
In four phases the investigators will evaluate physical activity and the validity, reliability, and responsiveness of the outcome measures in patients with polyneuropathy. During the four phases clinical outcome measures, patient-reported outcomes measures, and accelerometer data on physical activity will be evaluated. The investigators plan to include 400 adult patients with polyneuropathy (acquired, hereditary, and idiopathic) from our clinic and 120 adult healthy controls. The 400 patients with polyneuropathy include the following subtypes of polyneuropathy: Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), vasculitis polyneuropathy, Polyneuropathy-Organomegaly-Endocrinopathy-Monoclonal protein-Skin changes (POEMS syndrome), Multifocal Motor Neuropathy (MMN), Charcot Marie Tooth (CMT), hATTR amyloidosis, Diabetic Polyneuropathy (DPN), and idiopathic neuropathy.
Interventions
- Other Validity and reliability of outcome measures in polyneuropathy
Patients will be tested, answer patient reported outcome measures, and wear accelerometer at baseline after 2-4 weeks and after 1-2 years. - Other Healthy controls
Healthy controls will be tested, answer patient reported outcome measures, and wear accelerometer at baseline visit. There is no follow-up in the healthy control group.
Primary outcome measures
- 10-meter Walk Test [Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years]
- Six Spot Step Test [Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years]
- 6-minute Walk Test [Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years]
- 30 seconds Chair Stand Test [Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years]
- Dynamic Gait Index [Time frame: At baseline, after 2-4 weeks, and after 1-2 years]
- Nine Hole Peg Test [Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years]
- Jamar Hand-grip dynamometer (hand-grip-strength) [Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years]
- Isometric strength measured with hand-held dynamometer [Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years]
- Isokinetic muscle strength measured with Biodex System 3 or 4 PRO, Biodex Medical Systems [Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years]
- SENS motion activity sensor (accelerometer) [Time frame: At baseline (study entry), and after 1-2 years]
Secondary outcome measures (9)
- Rasch-build Overall Disability Scale for Immune-mediated peripheral neuropathies (I-RODS) [Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years]
- Falls Efficacy Scale-International (FES-I) [Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years]
- Composite Autonomic Symptom Score (COMPAS-31) [Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years]
- Self-reported Leeds Assessment of Neuropathic Symptoms and Signs (S-LANNS) [Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years]
- Fatigue Severity Scale (FSS) [Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years]
- PittsburghSleep Quality Index [Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years]
- Major Depression Inventory (MDI) [Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years]
- International Physical Activity Questionaire (IPAQ) [Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years]
- Physical Activity Scale (PAS2) [Time frame: At baseline (study entry), after 2-4 weeks, and after 1-2 years]
Eligibility criteria
Inclusion criteria
Inclusion Criteria patients:
> 18 years Diagnosed with polyneuropathy (verified by nerve conduction)
Inclusion Criteria healthy controls:
> 18 years Healthy
Exclusion criteria
Exclusion Criteria patients:
Not verified polyneuropathy
Exclusion Criteria healthy controls:
Diabetes, brain-, nerve-, muscle-, kidney-, or liver disease. Diagnosed with polyneuropathy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
Denmark · 1 center
- Copenhagen Neuromuscular Center, Rigshospitalet — Copenhagen
Identifiers
NCT: NCT06040567 · H-23032160